Two Approaches of Transversus Abdominis Block (TAP ) in Laparoscopic Cholecystectomy

NCT ID: NCT05946733

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-26
• Study Completion Date: 2024-01-25

Brief Summary

the investigators will compare the effect of pre-operative oblique subcostal TAP and lateral TAP blocks on the total perioperative opioids consumption for patients undergoing elective laparoscopic cholecystectomy

Detailed Description

General anesthesia induction will be achieved using a sleeping dose of fentanyl 1µg/kg intravascular(IV), propofol 2mg/kg (IV), and atracurium 0.5mg/kg (IV) to facilitate tracheal intubation. General anesthesia will be maintained with lungs ventilation by pressure controlled mode with isoflurane

During anesthesia maintenance Intraoperatively, if blood pressure BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine (3- 5mg) will be given to stabilize the patients' haemodynamics. Fifteen minutes before the end of surgery all patients will receive 1g intravenous paracetamol and 4 grams ondansetron.

Patients will be randomly divided into three equal groups:

Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. Group C :will receive postoperative morphine by patient-controlled analgesia (PCA).

Conditions

Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

subcostal TAP block

Group Type: EXPERIMENTAL

Group A

Intervention Type: PROCEDURE

After induction of general anesthesia, oblique subcostal TAP blocks will be done(14) under the guidance of Sonosite ,superficial probe ,14-15 MHz ultrasound transducer

Group B

lateral TAP block.

Group Type: EXPERIMENTAL

Group B

Intervention Type: PROCEDURE

After induction of general anesthesia, bilateral lateral TAP block will be performed (15) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz)

GroupC

will receive postoperative morphine by patient-controlled analgesia (PCA).

Group Type: OTHER

Group C

Intervention Type: OTHER

the analgesia will be maintained using a morphine patient-controlled analgesia (PCA) device set to give 1.5 mg bolus administration of morphine without a basic rate and 15 min lock-out time. The total amount of morphine administration will be recorded for the subsequent 24 h

Interventions

Group A

After induction of general anesthesia, oblique subcostal TAP blocks will be done(14) under the guidance of Sonosite ,superficial probe ,14-15 MHz ultrasound transducer

Intervention Type: PROCEDURE

Group B

After induction of general anesthesia, bilateral lateral TAP block will be performed (15) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz)

Intervention Type: PROCEDURE

Group C

the analgesia will be maintained using a morphine patient-controlled analgesia (PCA) device set to give 1.5 mg bolus administration of morphine without a basic rate and 15 min lock-out time. The total amount of morphine administration will be recorded for the subsequent 24 h

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Eligible patients will be older than 21 years old with American society of anaesthesia physical status I& II scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria

• - Uncooperative.
• Patients who have allergy to any of the study drugs.
• Patients who are on opioids.
• Known abuse of alcohol or medication.
• Local infection at the site of injection or systemic infection.
• Pregnancy.
• Patients with coagulation disorders or on anticoagulation therapy.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Amal Gouda Elsayed Safan

Lecturer of Anesthesiology, Intensive Care and Pain Management Faculty of Medicine - Menoufia University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AMAL G SAFAN, MD

Role: STUDY_DIRECTOR

Menoufia University

Locations

Menoufia University

Cairo, Shibin Elkom, Egypt

Countries

Egypt

Other Identifiers

11/2022ANET10-26

Identifier Type: -

Identifier Source: org_study_id